Recruiting

Extubation Advisor

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT05506904

Conditions

Airway Extubation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Extubation Advisor

Study Details

Brief summary:

Timely and safe extubation in critically ill patients is vitally important as prolonged mechanical ventilation and failed attempts at extubation are associated with increased morbidity, mortality, costs, intensive care unit (ICU) stays, and a risk for aerosolization of COVID-19 to health care providers. A Spontaneous Breathing Trial (SBT) is the current standard of care to assess a patient's readiness for extubation. However, SBTs are performed in various ways and have poor ability to predict successful extubation on their own. There is an urgent need to improve and standardize extubation decision-making. In a prior multicenter study, the investigators showed that decreased respiratory rate variability during SBTs predicted extubation failure better than other predictive indices.

The Extubation Advisor (EA) tool combines clinician's assessments of extubation readiness with predictive analytics and risk mitigation strategies for individual patients. In a single centre observational study, the investigators demonstrated the ability to deliver EA reports to the bedside and acceptability of this decision-support tool to respiratory therapists (RTs) and physicians (MDs).

The investigators will conduct the Liberation from mechanical ventilation using EA Decision Support (LEADS) Pilot Trial to assess feasibility outcomes. They will include critically ill adults who are invasively ventilated for >48 hours and are ready to undergo an SBT.

Patients in the intervention arm undergo an EA assessment and treating clinicians (RTs, MDs) will receive an EA report for each SBT conducted. The EA report will help to guide extubation decision-making. Patients in the control arm receive standard care. SBTs will be directed by clinicians.

The primary feasibility outcome will reflect the ability to recruit the desired population. The investigators will also assess the usefulness of the tool to MDs and complete an analysis of resource utilization to inform future economic analyses of cost-effectiveness. The investigators aim to recruit 1 to 2 patients/month/center.

The LEADS trial is novel and low-risk. It is the first trial to evaluate use of a bedside decision support tool to assist ICU clinicians with extubation decision-making. The LEADS pilot trial will inform the design of a future, large-scale randomized controlled trial that is expected to enhance the care delivered to critically ill patients, improve extubation outcomes, and inform extubation practice in ICUs.

Conditions

Airway Extubation

Study ID

NCT05506904

Start date

Apr 22, 2024

Status verified date

Apr, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Critically ill adults (age≥18)
  • Invasive ventilation for >48 hours
  • Who are expected to undergo an initial SBT within the next 48 hours with a view to extubation as per treating MDs. As per the FAST trial, an SBT will be defined as a focused assessment on low ventilator settings \[T-piece, continuous positive airway pressure (CPAP), or PS < 8 cm H2O regardless of positive end-expiratory pressure (PEEP)

Exclusion Criteria:

  • Suffer from known or suspected peripheral severe myopathy or neuropathy, or limb weakness or paralysis or central (e.g., post arrest, large intracranial stroke or bleed) injury or Glasgow Coma Scale (GCS) < 6
  • Do not wish to be re-intubated as part of their treatment goals
  • Were previously extubated during the same ICU admission
  • Have undergone 1 or more SBTs where the SBT was clearly documented in the chart and/or the PS was reduced to the SBT level of 8 or less during the 24 hour period prior to randomization
  • Already have a tracheostomy
  • Are moribund or expected to die.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Extubation Advisor

Wave form data from participants' spontaneous breathing trials (SBT) will be analyzed using Extubation Advisor (EA) to generate an EA report that provides clinical decision support regarding extubation.

no intervention: Standard of Care Arm

Participants will undergo SBTs as directed by clinicians. The EA device will not be used.

Interventions

Extubation Advisor

Participants undergoing a Spontaneous Breathing Trial (SBT) to assess readiness for extubation will be connected to a portable monitor displaying ECG, capnography, and other waveforms. This monitor will also be connected to a laptop containing the Extubation Advisor (EA) software. During the SBT, relevant patient information will be entered into the EA application and the EA application will record waveform data. When the SBT is complete, the EA application will analyze the waveform and patient data to generate a score summarizing the risk of extubation failure. A report will be generated and provided to the respiratory therapist and attending physician to help determine whether to proceed with extubation or not. The clinical outcome case report form will be completed at the time of hospital discharge.

Primary outcome measure

  • Evaluate the feasibility of enrolling 1-2 patients per centre per month [ Time Frame: Upon study completion, 12 months after study initiation ]

Central Contacts and Locations

Central contacts

Andrew JE Seely, MD PhD FRCSC

613-737-8899aseely@toh.ca

Karen Burns, MD MSc FRCPC

karen.burns@unityhealth.to

Locations

Royal Alexandra Hospital

Recruiting

Edmonton, Alberta, Canada, T5H 3V9

Principal Investigator:

Demetrios J Kutsogiannis, MD MHS FRCPC

St. Boniface Hospital

Recruiting

Winnipeg, Manitoba, Canada, R2H 2A6

Principal Investigator:

Owen Mooney, MD FRCPC

Health Sciences Centre Winnipeg

Recruiting

Winnipeg, Manitoba, Canada, R3A 1R9

Principal Investigator:

Asher Mendelson, MD PhD FRCPC

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K7L 2V7

Principal Investigator:

David Maslove, MD MS FRCPC

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H 8L6

Contacts

Andrew JE Seely, MD PhD FRCSC

613-737-8899aseely@toh.ca

Principal Investigator:

Alexander Tran, MD FRCPC

Queensway Carleton Hospital

Recruiting

Ottawa, Ontario, Canada, K2H 8P4

Principal Investigator:

Akshai M Iyengar, MSc MD FRCPC

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Principal Investigator:

Damon Scales, MD PhD FRCPC

Unity Health Toronto - St. Michael's Hospital

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Karen Burns, MD MSc FRCPC

karen.burns@unityhealth.to

Principal Investigator:

Karen Burns, MD MSc FRCPC

Hotel Dieu de Levis

Recruiting

Lévis, Quebec, Canada, G6V 3Z1

Principal Investigator:

Patrick Archambault, MD FRCPC

Centre hospitalier de l'Université de Montréal (CHUM)

Recruiting

Montreal, Quebec, Canada, H2X 3E4

Principal Investigator:

Emmanuel Charbonney, MD PhD

Hopital de l'Enfant Jesus

Recruiting

Québec, Quebec, Canada, G1J 1Z4

Principal Investigator:

Alexis F Turgeon, MD, MSc, FRCPC

Institut universitaire de cardiologie et de pneumologie de Québec

Recruiting

Ste-Foy, Quebec, Canada, G1V 4G5

Principal Investigator:

Francois Lellouche, MD PhD FRCPC

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Apr 22, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2026-04-22.